Identity
- Trade Name
- BD Molecular Swab Collection Kit FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Molecular Swab Collection Kit 100EA FDA UDI
- Model / Reference
- 443925 FDA UDI
- Description
- Molecular Swab Collection Kit 100EA FDA UDI
Identifiers
- Catalog Number
- 443925 FDA UDI
- Primary DI / UDI-DI
- 00382904439255 FDA UDI
- 510(k) Number
- K201017 FDA UDI
- FDA Product Code
- PQA FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3975 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
BD Molecular Swab Collection Kit by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
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- binx io — Binx Health, Inc. · Class I
- Visby Medical Women's Sexual Health Test — Visby Medical, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Visby Medical Power Adapter, Right Angle — Visby Medical, Inc. · Class II
Cleared under the same submission
K201017 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 6e376d56-8105-4d8b-bfe3-d465291124fe 37 fields · synced Jun 8, 2026